US2026053782A1PendingUtilityA1

Treatment regimens for parkinson's disease

63
Assignee: BIAL PORTELA & CA SAPriority: Aug 18, 2022Filed: Aug 17, 2023Published: Feb 26, 2026
Est. expiryAug 18, 2042(~16.1 yrs left)· nominal 20-yr term from priority
Inventors:SOARES DA SILVA PATRICIODA COSTA DE PINHO ROCHA JOSÉ FRANCISCO
A61K 31/198A61K 31/165A61P 25/16A61K 31/4439
63
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Claims

Abstract

A method of treating Parkinson's disease in a patient who is receiving N doses of levodopa per day to provide a total daily dose of X mg of levodopa and who is starting to experience motor fluctuations or starting to show signs of “wearing-off”, the treatment comprising administering more than N doses of levodopa per day to provide a total daily dose of X mg of levodopa and administering a single daily dose of Y mg of opicapone, wherein X is from 100 to 1000, N is from 2 to 10 and Y is from 25 to 50.

Claims

exact text as granted — not AI-modified
1 . A method of treating Parkinson's disease in a patient who is receiving N doses of levodopa per day to provide a total daily dose of X mg of levodopa and who is starting to experience motor fluctuations or starting to show signs of “wearing-off”, the treatment comprising administering more than N doses of levodopa per day to provide a total daily dose of X mg of levodopa and administering a single daily dose of Y mg of opicapone, wherein X is from 100 to 1000, N is from 2 to 10 and Y is from 25 to 50. 
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . The method according to  claim 1 , wherein the Parkinson's disease is idiopathic Parkinson's disease. 
     
     
         5 . The method according to  claim 1 , wherein N is 3 to 6. 
     
     
         6 . The method according to  claim 5 , wherein N is 4. 
     
     
         7 . The method according to  claim 1 , wherein X is 300 to 600. 
     
     
         8 . The method according to  claim 7 , wherein X is 400. 
     
     
         9 . The method according to  claim 1 , wherein Y is 25 or 50. 
     
     
         10 . The method according to  claim 9 , wherein the patient is receiving 4 doses of levodopa to provide a total daily dose of 400 mg per day and the treatment comprises administering 5 doses of levodopa per day to provide a total daily dose of 400 mg of levodopa and administering a single daily dose of 50 mg of opicapone. 
     
     
         11 . The method according to  claim 1 , wherein the levodopa dosage amount is not the same for every dose. 
     
     
         12 . The method according to  claim 11 , wherein the levodopa dosage amount is higher for odd numbered doses. 
     
     
         13 . The method according to  claim 11 , wherein the levodopa dosage amount is higher for even numbered doses. 
     
     
         14 . The method according to  claim 10 , wherein the 5 doses of levodopa to provide a total daily dose of 400 mg of levodopa are administered in the following dosing regimen: 100 mg, 50 mg, 100 mg, 50 mg and 100 mg. 
     
     
         15 . The method according to  claim 1 , wherein the single daily dose of opicapone is administered at least 1 hour after the last dose of levodopa. 
     
     
         16 . The method according to  claim 1 , wherein the patient is receiving N doses of a dopamine decarboxylase inhibitor (DDCI) to provide a total daily dose of Z mg of the DDCI, the method further comprising administering more than N doses of the DDCI per day to provide a total daily dose of Z mg of DDCI, wherein Z is from 50 to 250. 
     
     
         17 . The method according to  claim 16 , wherein the DDCI is carbidopa or benserazide. 
     
     
         18 . The method according to  claim 16 , wherein the DDCI doses are administered together with the levodopa doses. 
     
     
         19 . The method according to  claim 17 , wherein the patient is receiving 4 doses of carbidopa to provide a total daily dose of 100 mg per day and the treatment comprises administering 5 doses of carbidopa per day to provide a total daily dose of 100 mg of carbidopa. 
     
     
         20 . The method according to  claim 1 , wherein the treatment results in a reduction in “time to best ON”. 
     
     
         21 . The method according to  claim 1 , wherein the treatment results in a decrease in ON-time with troublesome dyskinesia. 
     
     
         22 . The method according to  claim 1 , wherein the treatment results in an improvement in the patient global impression of change.

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